Bilassa Tablet ENG sPAR - 09001bee81ad53db
Bilassa Tablet ENG sPAR - 09001bee81ad53db
Bilassa Tablet ENG sPAR - 09001bee81ad53db
Bilassa
(bilastine)
SE/H/2038/01/DC
Bilassa
bilastine
Tablet, 20 mg
This is a summary of the public assessment report (PAR) for Bilassa. It explains how Bilassa
was assessed and its authorisation recommended as well as its conditions of use. It is not
intended to provide practical advice on how to use Bilassa.
For practical information about using Bilassa, patients should read the package leaflet or
contact their doctor or pharmacist.
Bilassa is a ‘generic medicine’. This means that Bilassa is similar to a ‘reference medicine’
already authorised in the European Union (EU) called Bilaxten.
Bilassa is used to relieve the symptoms of hay fever (sneezing, itchy, runny, blocked-up nose
and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy
skin rashes (hives or urticaria).
Please read section 3 of the package leaflet for detailed information on dosing
recommendations, the route of administration, and the duration of treatment.
Because Bilassa is a generic medicine, studies in patients have been limited to tests to
determine that it is bioequivalent to the reference medicine, Bilaxten.
Because Bilassa is a generic medicine, its benefits and possible side effects are taken as being
the same as the reference medicine. For the full list of restrictions, see the package leaflet.
Why is Bilassa approved?
It was concluded that, in accordance with EU requirements, Bilassa has been shown to have
comparable quality and to be bioequivalent to the reference medicine Bilaxten. Therefore, the
Medical Products Agency in Sweden decided that, as for Bilaxten, the benefits are greater
than its risks and recommended that it can be approved for use.
What measures are being taken to ensure the safe and effective use of Bilassa?
A risk management plan has been developed to ensure that Bilassa is used as safely as
possible. Based on this plan, safety information has been included in the summary of product
characteristics and the package leaflet for Bilassa, including the appropriate precautions to be
followed by healthcare professionals and patients.
Known side effects are continuously monitored. Furthermore, new safety signals reported by
patients/healthcare professionals will be monitored/reviewed continuously as well.
The full PAR for Bilassa can be found on the following website:
http://mri.medagencies.org/Human/. For more information about treatment with Bilassa,
please read the package leaflet or contact your doctor or pharmacist.